FDA Adverse Event
Death
Summary report: N
POLYFLUX S CAPILLARY DIALYZER
MDR report key: 1051291
·
Received May 20, 2008
Report
- Report Number
- 9611369-2008-00352
- Event Type
- Death
- Date Received
- May 20, 2008
- Date of Event
- April 18, 2008
- Report Date
- April 21, 2008
- Manufacturer
- GAMBRO DIAYLZATOREN GMBH
- Product Code
- KDI
- PMA / PMN Number
- K010667
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE CLINICAL INVESTIGATION PROCESS IS STILL ONGOING. TO DATE, WE HAVE NO INFORMATION THAT REASONABLE INDICATES THAT THE DIALYZER HAS CAUSED OR CONTRIBUTED TO THE EVENT. GAMBRO DOES NOT REGARD THE SUBMISSION OF THIS REPORT AS AN ADMISSION OF LIABILITY.
Description of Event or Problem · 1
JUST FEW MINUTES AFTER THE TREATMENT STARTED, THE PATIENT COMPLAINED OF FEELING BAD. HIS CONDITION DETERIORATED QUICKLY AND WITHIN FIVE MINUTES AFTER HE SHOWED SYMPTOMS OF OEDEMA WITH SWELLING OF FACE AND TONGUE. MEDICAL INTERVENTION WITH INJECTION OF ADRENALIN AND CORTICOIDS DIDN'T SUCCEED AND THE PATIENT DIED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | POLYFLUX S CAPILLARY DIALYZER | KDI | GAMBRO DIAYLZATOREN GMBH | POLYFLUX 24 S | 8-2900-H-01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Death |